Recall Z-1286-2015 ยท FPA Set, Administration, Intravascular
Smiths Medical ASD, Inc.
CADD" Medication Cassette Reservoir, 50mL, REF 21-7001-24 & 21-7301-24, Sterile EO, Rx only.
| Date | Mar 17, 2015 (initiated Feb 2, 2015) |
| Status | Terminated |
| Reason | Smiths Medical has become aware of an issue with specific lots of 50mL CADD" Medication Cassette Reservoirs (Cassette). Some Cassettes may leak at the sealing area of the pump tube and medication bag. Smiths Medical has received no reports of serious injury or death related to this issue. |
| Root cause | Under Investigation by firm |
| Action | Smiths Medical sent an "Urgent Medical Device Recall" letter dated February 2, 2015, to all affected customers. The letter was addressed to Risk Safety Manger, Biomedical Professionals, Clinicians who oversee the use of CADD pumps, Distributors, and other users of these devices. The letter described the problem and the product involved in the recall. The letter also addressed the "Advice on Action to be Taken by the User", and "Transmission of this Urgent Recall Notice". Customers were requested to complete and return the Confirmation Form by Fax to 1-800-237-8033 or be email to recall.resp |
| Quantity | 48,208 (17,040 US, 31,168 OUS). |
| Distribution | Worldwide Distribution - US (nationwide) Distribution to the states of : AL, AZ, AR, CA, CO, CT, FL, GA, HI, IL IN, IA, MD, MA, MN, MS, MO, NE, NV, NH ,NJ, NM, NY, NC, OH, OR, PA, SD, TN, TX, UT, VA and WA., and to the countries of : Arab Emirates, Austria, Australia, Belgium, Canada, Switzerland, C |
| FDA record | Open on fda.gov |